Quality and Compliance

 

Placing a product on the market requires taking responsibility and a rooting in both international and local regulations and environments. Your quality and compliance systems need to verify and guarantee a good quality of the product and ensure security for the patients. Perhaps you need a wholesale dealers’ authorisation, or need to perform a self-inspection or audit? At Sofus, we provide expertise on how to effectively organize and maintain the quality management system throughout the life cycle of your pharma, biotech or medical device product. We also assist you in keeping your company and processes compliant with the safety and ethical requirements.

 

Success is all about quality

Your quality management system needs to verify and guarantee a good quality of the product and security for the patients. Since many years, Sofus provides services from trustworthy QA experts that include strategic advice, audits and inspections, acting as responsible person (GDP) or qualified person (GMP), systems for deviations and CAPA, complaints management and much more.

We have experience from GXP (GDP, GMP, GLP, GVP) and ISO environments, from labelling of medical devices, the technical dossier and from CE-applications. Our experienced team will assist you with their proactive, hands-on attitude and expertise, making sure your quality obligations do not burden, but rather enhance, your business.

Trust us with your product safety

Pharmacovigilance, medical information and management of complaints often function as a patient’s or healthcare professional’s first contact point to a company regarding a product. It is important to manage this contact and the information given with care, to support the company’s business, manage the product risks and maintain product safety.

Our dedicated team are available to make sure that your safety matters are handled in a structured and reliable way, and that the safety features of your product are well taken care of. On a daily basis we receive ICSRs, performs triage and quality control, perform case entering as well as archive and follow-up AE cases and ADRs. Of course, we perform literature searches as well.

Complement your promotion and marketing team

Taking responsibility for your product also includes taking responsibility for the marketing of the product. We keep up to date with the ethical framework in the Nordics through an effective work routine established since many years. This way, we can complement your own team by adding a strong, responsible expertise for the review of all your promotion and marketing material.

 

Contact Us:

Maria Äng
Partner. Director Quality and Compliance Services
Phone: +46 8 5600 2029
maria.ang(at)sofus.se